Children's Daytime Cold & Cough Nighttime Congestion And Cold

Children's Daytime Cold & Cough Nighttime Congestion And Cold
SPL v2
SPL
SPL Set ID 2cf361eb-6055-2364-e063-6294a90a69a1
Route
ORAL
Published
Effective Date 2025-02-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Brompheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg) Diphenhydramine (6.25 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propyl Gallate Propylene Glycol Water Sorbitol Sucralose Sodium Benzoate Sodium Citrate, Unspecified Form Sodium Citrate

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-31
Description

Brompheniramine Maleate 1 mg  Dextromethorphan HBr 5 mg  Phenylephrine HCI 2.5 mg 

Purpose

Antihistamine Cough suppressant Nasal decongestant

Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Brompheniramine Maleate 1 mg  Dextromethorphan HBr 5 mg  Phenylephrine HCI 2.5 mg 

Use(s)


DAYTIME

  • temporarily relieves cough due to minor

    bronchial irritation as may occur with a cold, and

    nasal congestion due to the common cold, hay

    fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay

    fever (allergic rhinitis): • sneezing • itching of the

    nose or throat • runny nose • itchy, watery eyes
  • temporarily restores freer breathing through the nose


NIGHTTIME



  • tempuradly relieves these symptoms occuring with

    a cold, hay fever or other upper respiratory allergies:

    • sneezing. itching of the nose or throat. runny nose

    • itchy, watery eyes. cough. nasal congestion
Warnings

.

Directions


DAYTIME

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon


Age  Dose  
adults & children 12 years over 

  4 tsp (20 mL) every 4 hours
children 6 years to under 12 years

  2 tsp (10 mL) every 4 hours
children under 6 years  do not use




NIGHTTIME 

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon


Age  Dose  
adults & children

12 years over 

  4 tsp (20 mL) every 4 hours
children 6 years to

under 12 years

  2 tsp (10 mL) every 4 hours
children under 6 years  do not use


Do Not Use

Daytime

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or   Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an  MAOI, ask a doctor or   pharmacist before taking this product.

Nighttime

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do nut know if your prescription drug contains an MAOI, ask a doctor

    or pharmacist before taking this product.
  • with any other product containing diphenhydramine, even one used on skin
Other Information


DAYTIME

  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF)
  • measuring cup provided



     


NIGHTTIME



  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF) 
  • measuring cup provided
Purpose for Daytime

Antihistamine

Cough suppressant

Nasal decongestant

Inactive Ingredients

DAYTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose



NIGHTTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red  #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Purpose for Nighttime

Antihistamine / Cough suppressant

Nasal Decongestant

Principal Display Panel

DAY/NIGHT PACK

NDC 51316-939-04

CVS Health 

Compare to the a ctive Ingredients in Children's Dimetapp® Cold & Cough*

Compare to the a ctive Ingredients in Children's Dimetapp® Nighttime Cold & Cough*

 

Children's Daytime Cold & Cough

 

BROMPHENIRAMINE MALEATE

Antihistamine

DEXTROMETHORPHAN HBr

Cough suppressant



PHENYLEPHRINE HCl

Nasal decongestant



DM Liquid

Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes



Calms allergy symptoms

Soothes Cough

Alcohol Free



Grape Flavor

Ages 6 Years & Over



4 FL OZ (118 mL)



Children's Nighttime Congestion & Cold 

 

DIPHENYLHYDRAMINE HCl

Cough suppressant; Antihistamine

 

PHENYLEPHRINE HCl

Nasal decongestant



Liquid



Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes



Calms allergy symptoms

Soothes Cough



Alcohol Free



Grape Flavor

Ages 6 Years & Over



4 FL OZ (118 mL)







When Using This Product

DAYTIME 

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

  NIGHTTIME

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask Doctor If
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious

    condition.
If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.



Ask A Doctor Before Use If You Have


DAYTIME

  • heart disease 
  • glaucoma 
  • diabetes 
  • thyroid disease 
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs wilt too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema


 

NIGHTTIME



  • heart disease 
  • glaucoma 
  • diabetes
  • thyroid disease 
  • high blood pressure 
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredient(s) for Daytime (in Each 5 Ml)

Brompheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg 

Ask A Doctor Or Pharmacist Before Use If You Are

DAYTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers

 

NIGHTTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers
Active Ingredient(s) for Nighttime (in Each 5 Ml)

Diphenhydramine HCI 6.25 mg

Phenylephrine HCI 2.5 mg 

Structured Label Content

Use(s) (USE(S))


DAYTIME

  • temporarily relieves cough due to minor

    bronchial irritation as may occur with a cold, and

    nasal congestion due to the common cold, hay

    fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay

    fever (allergic rhinitis): • sneezing • itching of the

    nose or throat • runny nose • itchy, watery eyes
  • temporarily restores freer breathing through the nose


NIGHTTIME



  • tempuradly relieves these symptoms occuring with

    a cold, hay fever or other upper respiratory allergies:

    • sneezing. itching of the nose or throat. runny nose

    • itchy, watery eyes. cough. nasal congestion
Warnings (WARNINGS)

.

Directions (DIRECTIONS)


DAYTIME

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon


Age  Dose  
adults & children 12 years over 

  4 tsp (20 mL) every 4 hours
children 6 years to under 12 years

  2 tsp (10 mL) every 4 hours
children under 6 years  do not use




NIGHTTIME 

  • do not take more than 6 doses in any 24-hour period
  • do not exceed recommended dosage
  • mL milliliter
  • tsp = teaspoon


Age  Dose  
adults & children

12 years over 

  4 tsp (20 mL) every 4 hours
children 6 years to

under 12 years

  2 tsp (10 mL) every 4 hours
children under 6 years  do not use


Do Not Use (DO NOT USE)

Daytime

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or   Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an  MAOI, ask a doctor or   pharmacist before taking this product.

Nighttime

Do not use

  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do nut know if your prescription drug contains an MAOI, ask a doctor

    or pharmacist before taking this product.
  • with any other product containing diphenhydramine, even one used on skin
Other Information (OTHER INFORMATION)


DAYTIME

  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF)
  • measuring cup provided



     


NIGHTTIME



  • each teaspoon (tsp) contains: sodium 5 mg
  • store at 20-25ºC (68-77ºF) 
  • measuring cup provided
Purpose for Daytime (PURPOSE FOR DAYTIME)

Antihistamine

Cough suppressant

Nasal decongestant

Inactive Ingredients (INACTIVE INGREDIENTS)

DAYTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose



NIGHTTIME

anhydrous citric acid, artificial flavor, FD&C blue #1, FD&C red  #40, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Purpose for Nighttime (PURPOSE FOR NIGHTTIME)

Antihistamine / Cough suppressant

Nasal Decongestant

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

DAY/NIGHT PACK

NDC 51316-939-04

CVS Health 

Compare to the a ctive Ingredients in Children's Dimetapp® Cold & Cough*

Compare to the a ctive Ingredients in Children's Dimetapp® Nighttime Cold & Cough*

 

Children's Daytime Cold & Cough

 

BROMPHENIRAMINE MALEATE

Antihistamine

DEXTROMETHORPHAN HBr

Cough suppressant



PHENYLEPHRINE HCl

Nasal decongestant



DM Liquid

Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes



Calms allergy symptoms

Soothes Cough

Alcohol Free



Grape Flavor

Ages 6 Years & Over



4 FL OZ (118 mL)



Children's Nighttime Congestion & Cold 

 

DIPHENYLHYDRAMINE HCl

Cough suppressant; Antihistamine

 

PHENYLEPHRINE HCl

Nasal decongestant



Liquid



Relieves:

Nasal congestion; Stuffy nose;

Runny nose; Sneezes



Calms allergy symptoms

Soothes Cough



Alcohol Free



Grape Flavor

Ages 6 Years & Over



4 FL OZ (118 mL)







When Using This Product (WHEN USING THIS PRODUCT)

DAYTIME 

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

  NIGHTTIME

  • do not take more than directed
  • may cause drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic beverages
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)
  • nervousness, dizziness or sleeplessness occur
  • symptoms do not improve within 7 days or are accompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious

    condition.
If Pregnant Or Breast Feeding (IF PREGNANT OR BREAST-FEEDING)

ask a health professional before use.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

In case of overdose, get medical help or contact a Poison Control Center right away.



Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)


DAYTIME

  • heart disease 
  • glaucoma 
  • diabetes 
  • thyroid disease 
  • high blood pressure
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs wilt too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema


 

NIGHTTIME



  • heart disease 
  • glaucoma 
  • diabetes
  • thyroid disease 
  • high blood pressure 
  • difficulty in urination due to an enlarged prostate gland 
  • cough that occurs with too much phlegm (mucus) 
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
Active Ingredient(s) for Daytime (in Each 5 Ml) (ACTIVE INGREDIENT(S) FOR DAYTIME (in each 5 mL))

Brompheniramine Maleate 1 mg 

Dextromethorphan HBr 5 mg 

Phenylephrine HCI 2.5 mg 

Ask A Doctor Or Pharmacist Before Use If You Are (ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE)

DAYTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers

 

NIGHTTIME

  • taking any other oral nasal decongestant or stimulant 
  • taking sedatives or tranquilizers
Active Ingredient(s) for Nighttime (in Each 5 Ml) (ACTIVE INGREDIENT(S) FOR NIGHTTIME (in each 5 mL))

Diphenhydramine HCI 6.25 mg

Phenylephrine HCI 2.5 mg 

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Raw Label Data

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Source: dailymed · Ingested: 2026-02-15T12:05:28.518538 · Updated: 2026-03-14T23:07:22.014703